Adaptive DBS for PD (SMART-DBS)
17 juni 2026 uppdaterad av: Beijing Pins Medical Co., Ltd
Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms.
Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study.
Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes.
Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients.
Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study.
Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits.
During crossover testing, each participant will experience both stimulation modes sequentially while blinded.
Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters.
The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jianguang Sun
- Telefonnummer: +86 010-60736388
- E-post: sunjianguang@pinsmedical.com
Studera Kontakt Backup
- Namn: Qihang Shi
- Telefonnummer: +86 18511837185
- E-post: shiqihang@pinsmedical.com
Studieorter
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Anhui
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Hefei, Anhui, Kina
- Har inte rekryterat ännu
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
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Huvudutredare:
- Chaoshi Niu
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Har inte rekryterat ännu
- Peking Union Medical College Hospital
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Huvudutredare:
- Yi Guo
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Beijing, Beijing Municipality, Kina, 10000
- Rekrytering
- Beijing Tiantan Hospital, Capital Medical University
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Huvudutredare:
- Jianguo Zhang
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Kontakt:
- Hutao Xie
- Telefonnummer: +86 18756921517
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Beijing, Beijing Municipality, Kina, 10000
- Rekrytering
- Xuanwu Hospital, Capital Medical University
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Kontakt:
- Kailiang Wang
- Telefonnummer: +86 13521539544
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Huvudutredare:
- Guoguang Zhao
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Guangdong
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Guangzhou, Guangdong, Kina
- Har inte rekryterat ännu
- First Affiliated Hospital, Sun Yat-Sen University
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Huvudutredare:
- Jinsheng Zeng
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Underutredare:
- Ling Chen
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Hunan
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Changsha, Hunan, Kina
- Rekrytering
- Xiangya Hospital of Central South University
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Huvudutredare:
- Zhiquan Yang
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Jiangsu
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Nanjing, Jiangsu, Kina
- Rekrytering
- Nanjing Brain Hospital
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Kontakt:
- Chang Qiu
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Huvudutredare:
- Wenbin Zhang
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Shandong
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Jinan, Shandong, Kina
- Har inte rekryterat ännu
- Qilu Hospital of Shandong University
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Huvudutredare:
- Weiguo Li
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Sichuan
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Chengdu, Sichuan, Kina
- Har inte rekryterat ännu
- West China Hospital
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Huvudutredare:
- Wei Wang
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- idiopathic Parkinson's disease
- Hoehn & Yahr (HY) stage 2.5-4 during medication "OFF"
Subjects must meet one of the following:
- Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
- Previous bilateral STN/GPi DBS recipients with only one IPG who:
- Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
- Consent to device replacement with G1010R DBS system.
- Willing and physically/mentally able to complete all study visits and procedures
- Capable of comprehending and providing written informed consent
Exclusion Criteria:
- Presence of contraindications to deep brain stimulation (DBS) surgery.
- Beck Depression Inventory-II (BDI-II) score > 25
- Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
- Significant comorbidities that may interfere with DBS therapy per investigator assessment.
- Pre-existing active non-DBS medical implants or metallic cranial implants
- Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period
- History of ablative neurosurgery or stem cell therapy for Parkinson's disease
- Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
- Inability to maintain prescribed medication regimens or comply with protocol requirements
- Current pregnancy, lactation, or planned pregnancy during the study period
- Other conditions deemed by investigators to compromise study suitability
- Participation in other interventional clinical trials within 4 weeks prior to consent
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group A
Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.
|
adaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device.
aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.
Andra namn:
conventional deep brain stimulation is a common stimulation mode that has been used for years.
It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.
Andra namn:
|
|
Experimentell: Group B
Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.
|
adaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device.
aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.
Andra namn:
conventional deep brain stimulation is a common stimulation mode that has been used for years.
It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Tidsram: about one month each after randomization
|
In the Motor-Sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep.
The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia.
The Motor-Sleep Diary was collected at both the cDBS treatment and aDBS treatment during the crossover evaluation phases.
The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS.
The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
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about one month each after randomization
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Motor-sleep dairy
Tidsram: about one month after randomization
|
In the Motor-sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The Motor-sleep Diary also collects a visual analogue scale that subjects use to evaluate overall quality of sleep last night. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-sleep Diary was collected at the cDBS treatment and aDBS treatment during crossover evaluation phases. Motor-sleep Diary collects 5 measurements:
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about one month after randomization
|
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Recharging DBS Experience
Tidsram: about one month after randomization
|
Recharging DBS Experience measures the experience of subject recharge DBS device under each treatment.
It is evaluated by recharging interval and accumulation of electric energy depletion.
The numeric results are calculated using DBS recharging dairy embedded in the device.
The more frequently recharge or the more electric energy is depleted, the poor experience the subjects have.
The measurements will be collected for each treatment during crossover phase and will be compared.
|
about one month after randomization
|
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TEED
Tidsram: about one month after randomization
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Total Electric Energy Delivered(TEED) measures the amount of energy consumed by stimulation for each treatment.
The numeric result are estimated by DBS stimulation parameters.
The measurements will be collected for each treatment during crossover phase and will be compared.
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about one month after randomization
|
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Peripheral Device Measurements
Tidsram: about one month after randomization
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Peripheral device measurements include motor and sleep metrics that can offer extra symptom analysis.
The measurements will be collected for each treatment during crossover phase and will be compared.
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about one month after randomization
|
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GIC
Tidsram: about 14 days after programming during adjustment phase
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The Global Impression Change Score(GIC) measure the acceptance of each treatment after programming compared to the previous treatment.
It is evaluated by subject using effectiveness and side effect to acquire a status code that can be analyzed descriptively.
The measurements will be collected for each treatment during adjustment phase and will be compared.
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about 14 days after programming during adjustment phase
|
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MDS UPDRS
Tidsram: about one month after randomization
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The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each parts range as the following: 0~52, 0~52, 0~132, 0~24. Lower score means better rating on the according symptoms. Each measures different perspective of motor disorder. In this trial, 5 measurements will be collected:
The result of each treatment will be compared. |
about one month after randomization
|
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PDSS-2
Tidsram: about one month after randomization
|
Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease.
The scale ranges from 0 to 60. Lower score means better rating on sleep conditions.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases.
The result of each treatment will be compared.
|
about one month after randomization
|
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PSQI
Tidsram: about one month after randomization
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Pittsburgh sleep quality index(PSQI) measures the quality of sleep.
The scale ranges from 0 to 21. Lower score means better rating on the quality of sleep.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases.
The result of each treatment will be compared.
|
about one month after randomization
|
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PDQ-39
Tidsram: about 6 months after randomization
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Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease, containing 39 items that range from 0 to 4. The final score is computed through the following steps: 1. calculate the average score of every item in 8 dimensions and span the results to a range from 0 to 100; 2. calculate the average score of all dimensions.
The final score ranges from 0 to 100.
Lower score means better rating on the quality of life.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover.
The result of each treatment will be compared.
Overall result will be analyzed descriptively.
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about 6 months after randomization
|
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EQ-5D-5L
Tidsram: about 6 months after randomization
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EQ-5D-5L measures the quality of life, containing 5 questions and 1 visual analogue scale(VAS) for rating of subjective conclusive quality of life.
The results of 5 questions form a state code of 5 digits.
The state code will be transformed to EQ-5D index score using a values set for China.
Measurements will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover.
The results of each treatment will be compared.
Overall result will be analyzed descriptively.
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about 6 months after randomization
|
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Patient Preference Questionnaire
Tidsram: about 2 months after randomization
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Patient Preference Questionnaire measures the preference to each treatments while blinded.
The questionnaire contains 6 independent questions.
Each option of every question will be counted as a percentage.
Measurement will be collected at the end of last crossover phase before unblinding.
The result of each treatment will be compared and analyzed descriptively.
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about 2 months after randomization
|
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Patient Satisfaction Questionnaire
Tidsram: about 6 months after randomization
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Patient Satisfaction Questionnaire measures the satisfaction with each treatments.
The questionnaire contains 3 independent questions.
Each option of every question will be counted as a percentage.
Measurement will be collected at the end of entire trial before completion.
The result of each treatment will be compared and analyzed descriptively.
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about 6 months after randomization
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 maj 2026
Primärt slutförande (Beräknad)
31 maj 2027
Avslutad studie (Beräknad)
30 september 2027
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
3 juni 2026
Första postat (Faktisk)
9 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- G1010R&PINS-C2-01-53
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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